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Generated: April 23, 2019

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Insulin detemir recombinant - Generic Drug Details

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What are the generic drug sources for insulin detemir recombinant and what is the scope of insulin detemir recombinant freedom to operate?

Insulin detemir recombinant is the generic ingredient in five branded drugs marketed by Novo Nordisk Inc and is included in one NDA. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin detemir recombinant has two hundred and forty-five patent family members in thirty countries.

There are forty drug master file entries for insulin detemir recombinant. Four suppliers are listed for this compound.

Pharmacology for insulin detemir recombinant
Ingredient-typeInsulin
Drug ClassInsulin Analog
Medical Subject Heading (MeSH) Categories for insulin detemir recombinant
Synonyms for insulin detemir recombinant
169148-63-4
201305-44-4
270588-25-5
29(sup B)-(N(sup 6)-(1-Oxotetradecyl)-L-lysine)-(1(sup A)-21(sup A)),(1(sup B)-29(sup B))-insulin (human)
29(sup B)-(N(sup 6)-Myristoyl-L-lysine)-30(sup B)-de-L-threonineinsulin (human)
29B-(N6-Myristoyl-L-lysine)-30B-de-L-threonineinsulin (human)
4FT78T86XV
CHEMBL2104391
Insulin detemir
Insulin detemir [USAN:INN:BAN]
Levemir
Levemir Flexpen
Levemir Innolet
Levemir Insulin
Levemir Penfill
NN 304
NN-304
NN304
UNII-4FT78T86XV

US Patents and Regulatory Information for insulin detemir recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-001 Jun 16, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for insulin detemir recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc LEVEMIR PENFILL insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-004 Jun 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR PENFILL insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-004 Jun 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-001 Jun 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for insulin detemir recombinant

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 122013000061 Germany ➤ Try a Free Trial PRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
2107069 13C0035 France ➤ Try a Free Trial PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
0368187 SZ 34/2000 Austria ➤ Try a Free Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN
2340033 2017C/024 Belgium ➤ Try a Free Trial PRODUCT NAME: SNELWERKENDE INSULINE ASPART; AUTHORISATION NUMBER AND DATE: EU/1/16/1160 20170111
2498802 2017/022 Ireland ➤ Try a Free Trial PRODUCT NAME: A COMPOSITION COMPRISING INSULIN GLARGINE, OR A PHARMACOLOGICALLY TOLERABLE SAFT THEREOF, AND LIXISENATIDE, OR A PHARMACOLOGICALLY TOLERABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1157 20170111
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Baxter
Colorcon
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Julphar

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